All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
Introducing
Now you can personalise
your Lymphoma Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC View funders.
Bookmark this article
The U.S. Food and Drug Administration has placed a partial hold on clinical trials of the experimental drug selinexor (KPT-330), a XPO1 antagonist.
The trials have been halted by the FDA due to incomplete information in the Investigator’s Brochure (IB), which includes an incomplete list of Serious Adverse Events (SAEs) associated with selinexor. This partial clinical hold placed by the FDA prevents new patients to be enrolled into clinical trials with selinexor. However, patients with stable disease or better may remain on selinexor therapy. So far, nearly 2,000 patients have been treated with selinexor.
Consequently, at the FDA’s request, Karyopharm, the drug’s manufacturers, have amended the IB and the informed consent documents accordingly. The updated documents were submitted to the FDA on 10th March 2017.
Currently, selinexor is being evaluated in multiple studies in R/R patients with B-cell lymphoma, in particular aggressive DLBCL and CLL.
One such trial which has been suspended is a phase I trial (NCT02303392) investigating selinexor combined with ibrutinib for the treatment of R/R CLL/SLL and aggressive NHLs including MCL and DLBCL. Additionally, results of the SADAL trial (NCT02227251) comparing high and low doses of selinexor in R/R DLBCL patients are highly anticipated.
Understanding your specialty helps us to deliver the most relevant and engaging content.
Please spare a moment to share yours.
Please select or type your specialty
Your opinion matters
Subscribe to get the best content related to lymphoma & CLL delivered to your inbox